Regulatory PathRegulatory requirements compared

Active substance

Cefoxitin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FOXITIN 1GM VIAL I.V OR I.M ADMINISTRATI1 gpowder for solution for injection · Parenteral use1 VialSAR 30.05Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
Indications — CHI Daman Drug Formulary

ANTIBIOTIC SURGICAL PROPHYLAXIS; INTRA-ABDOMINAL INFECTIONS; PELVIC INFLAMMATORY DISEASE; PERITONITIS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
CEFOXITINEQ 10GM BASE/VIALinjectable · injectionHIKMA PHARMSPrescription11 Sep 2000
CEFOXITINEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionHIKMA PHARMSPrescription11 Sep 2000
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionB BRAUNPrescription10 Mar 2006
CEFOXITINEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionACS DOBFARPrescription12 Jun 2009
CEFOXITINEQ 10GM BASE/VIALinjectable · injectionHIKMA FARMACEUTICAPrescription26 Feb 2010
CEFOXITINEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionHIKMA FARMACEUTICAPrescription12 Mar 2010
CEFOXITINEQ 10GM BASE/VIALinjectable · injectionACS DOBFARPrescription19 May 2010
CEFOXITIN IN PLASTIC CONTAINEREQ 100GM BASEpowder · intravenousSAMSON MEDCLPrescription16 Nov 2015
MEFOXINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionPHARMOBEDIENTDiscontinued18 Oct 1978
MEFOXINEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionPHARMOBEDIENTDiscontinued8 Jan 1987
MEFOXIN IN PLASTIC CONTAINEREQ 20MG BASE/ML; EQ 40MG BASE/MLinjectable · injectionPHARMOBEDIENTDiscontinued25 Jan 1993
CEFOXITINEQ 10GM BASE/VIALinjectable · injectionFRESENIUS KABI USADiscontinued3 Jul 2000
CEFOXITINEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionFRESENIUS KABI USADiscontinued3 Jul 2000
CEFOXITINEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued23 Jan 2006
CEFOXITINEQ 10GM BASE/VIALinjectable · injectionHOSPIRA INCDiscontinued13 Feb 2006
CEFOXITINEQ 10GM BASE/VIALinjectable · injectionACS DOBFAR SPADiscontinued31 Aug 2011
CEFOXITINEQ 1GM BASE/VIAL; EQ 2GM BASE/VIALinjectable · injectionACS DOBFAR SPADiscontinued31 Aug 2011
MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionMERCKDiscontinued
MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionMERCKDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CEFOXITIN FOR INJECTION021281871 G / VIALPOWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULARTEVA CANADA LIMITED
CEFOXITIN FOR INJECTION021281952 G / VIALPOWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUSTEVA CANADA LIMITED

Safety signals and safety-related labeling changes

All safety entries for cefoxitin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.